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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01333397 |
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Date of registration:
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08/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Dysport RU and Glabellar Lines
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Scientific title:
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A Phase II, Double Blind, Randomised, Placebo and Active Comparator Controlled Study to Assess the Safety and Efficacy of Three Doses of Dysport RU (20 U, 50 U, and 75 U) Administered as a Single Treatment Cycle to Improve the Appearance of Moderate to Severe Glabellar Lines |
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Date of first enrolment:
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March 2011 |
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Target sample size:
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176 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01333397 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Germany
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Contacts
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Name:
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Ipsen Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ipsen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female between 30 - 60 years of age
- Moderate to severe vertical glabellar lines at maximum frown at baseline
Exclusion Criteria:
- Silicone injections into the upper face
- Any prior treatment with fillers (e.g. collagen-type implants) skin abrasions or
photorejuvenation within the previous 12 months
- Any planned facial cosmetic surgery during the study period
- A history of ablative skin resurfacing of the area to be treated during the study.
Age minimum:
30 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Glabellar Frown Lines
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Intervention(s)
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Drug: Placebo
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Biological: Botulinum toxin type A
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Primary Outcome(s)
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Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown
[Time Frame: Day 29]
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Secondary Outcome(s)
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Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)
[Time Frame: Day 29]
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Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.
[Time Frame: Days 8, 15, 29, 57, 85 and 113]
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Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
[Time Frame: Days 8, 15, 57, 85 and 113]
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Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.
[Time Frame: Day 29]
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Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)
[Time Frame: Days 8, 15, 29, 57, 85 and 113]
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Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment
[Time Frame: Days 8, 15, 29, 57, 85 and 113]
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Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment
[Time Frame: Days 8, 15, 29, 57, 85 and 113]
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Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)
[Time Frame: Days 8, 15, 29, 57, 85 and 113]
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Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.
[Time Frame: Days 8, 15, 57, 85 and 113]
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Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.
[Time Frame: Days 8, 15, 57, 85 and 113]
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Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)
[Time Frame: Days 8, 15, 29, 57, 85 and 113]
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Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment
[Time Frame: Days 8, 15, 29, 57, 85 and 113]
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Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders
[Time Frame: Day 113]
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Secondary ID(s)
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2010-019085-82
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Y-52-52120-146
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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